Navigation Links
Doctors Can Use Rotavirus Vaccine Again: FDA
Date:5/14/2010

Contaminant found in March no health risk, agency says

FRIDAY, May 14 (HealthDay News) -- Doctors can resume using the vaccine Rotarix to prevent rotavirus, a common cause of severe diarrhea in children, the U.S. Food and Drug Administration said Friday.

On March 22, the FDA recommended that doctors temporarily stop using the oral vaccine -- one of two brands available to prevent rotavirus -- because doses appeared to be contaminated with a benign pig virus.

The FDA said it wanted to identify the source of the contamination and make certain that any potential harm from contamination had been identified. The pig virus -- known as porcine circovirus 1 (PCV1) -- isn't known to cause illness in humans, FDA Commissioner Dr. Margaret Hamburg said at the time.

In a statement released Friday, the FDA said it had determined that "it is appropriate for clinicians and health care professionals to resume the use of Rotarix and to continue the use of RotaTeq," a second rotavirus vaccine.

The agency said it based its decision on an evaluation of information from laboratory results from the manufacturer (Rotarix is made by GlaxoSmithKline) and the FDA's own laboratories, as well as a review of the scientific literature and advice from scientific and public health experts.

In reaching its decision, the FDA cited both vaccines' safety records, which include clinical trials involving tens of thousands of patients as well as the experience of millions of vaccine recipients.

The agency said there's no evidence that PCV1 or PCV2 pose a safety risk in humans, and neither is known to cause infection or illness in humans.

The FDA also pointed to the vaccines' benefits, which it called "substantial."

According to the U.S. Centers for Disease Control and Prevention, rotavirus causes vomiting, fever and dehydration and is the leading cause of diarrhea in infants and young children. Almost all children in the United States are likely to be infected before they turn 5 years old.

Treatment includes replacing lost body fluids with drinkable products with water, sugar and minerals, the CDC advises.

More information

For more on rotavirus and the vaccines, visit the FDA.



-- HealthDay staff



SOURCES: May 14, 2010, news release, U.S. Food and Drug Administration


'/>"/>
Copyright©2010 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. Interruptions Make Doctors Lose Track of Tasks
2. Traffic Logix Solutions Protect Doctors and Patients at Northeastern Hospitals
3. Barbara Walters Prognosis Is Excellent, Doctors Say
4. Doctors use ultrasound to diagnose possible muscular trauma in professional athletes on-site
5. Harvard Health Letter Features Q&As from Harvard Doctors
6. Mom-Doctors: How they Balance Home and Career
7. Strategy to help doctors determine when to treat retinopathy of prematurity
8. AngioDynamics' VenaCure EVLTTM System for Varicose Veins To Be Featured On 'The Doctors' National Television Program
9. MarijuanaDoctors.com Announces Weed Team Contest Winner, Adds Additional Trip to the Cannabis Cup in Amsterdam
10. National Allergy Supply, The Allergy Products Company Recommended By More Than 9,500 Doctors Nationwide, Announces 100% Unconditional Satisfaction Guarantee
11. HCL Thames Medics says more locum doctors could help address European Working Time Directive shortage
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/6/2016)... ... 2016 , ... Research has shown that building shame resilience ... and level of relapse. , At the 2016 iaedp Symposium, the ... the critical tasks of the recovery phase and beyond including relapse prevention and ...
(Date:2/5/2016)... , ... February 05, 2016 , ... ... availability of the company's lighter, sleeker next generation LYNX VR Indoor Trainer with ... , Improvements in design and manufacturing not only reduce the weight of the ...
(Date:2/5/2016)... ... , ... The event is being held on April 7, 2016 from 5:30 ... Over Parkinson’s will fund nearly $100,000 for research for the care and cure of ... and is the architect of this informative event to raise awareness and funds for ...
(Date:2/5/2016)... ... February 05, 2016 , ... Looking for a last-minute Valentine’s Day ... tips of your toes. Foot massage, whether administered by a professional masseuse or a ... The American Board of Multiple Specialties in Podiatry (ABMSP) has taken the ...
(Date:2/5/2016)... Florida (PRWEB) , ... February 05, 2016 , ... ... non-profit organization devoted exclusively to funding innovative lymphoma research and serving the lymphoma ... – is poised to once again host, Swirl, A Wine Tasting Event at ...
Breaking Medicine News(10 mins):
(Date:2/4/2016)... , Feb. 4, 2016 Worldwide Radiology ... significant growth as next generation systems provide a ... radiology for cancer surgery. New systems pinpoint the ... that has been such a problem previously, limiting ... Radiosurgery robots take cancer surgery far beyond what ...
(Date:2/4/2016)... LONDON , Feb. 4, 2016 ... Summary Global Markets Direct,s, ,Wegener Polyangiitis - ... the Wegener Polyangiitis,s therapeutic pipeline. This report ... Wegener Polyangiitis, complete with comparative analysis at various ... action (MoA), route of administration (RoA) and molecule ...
(Date:2/4/2016)... , Feb. 4, 2016 Global ... competitive market to drive long-term market growth ... common set of chronic disorders that affect 5–7% ... in terms of their symptoms and key patient ... dysregulation of immune pathways and an inappropriate immune ...
Breaking Medicine Technology: